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ORACLE ORAL MASK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003894
510(k) Type
Traditional
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
6/25/2001
Days to Decision
189 days
Submission Type
Summary

ORACLE ORAL MASK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003894
510(k) Type
Traditional
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
6/25/2001
Days to Decision
189 days
Submission Type
Summary